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ViiV seeks USFDA approval to expand Cabenuva use for HIV-1 infected

ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva. ....

Kimberly Smith , Viiv Healthcare Research , Drug Administration , Viiv Healthcare , Janssen Science , Antiretroviral Therapy , Long Acting Suppression , கிம்‌பர்லீ ஸ்மித் , ஜான்சன் அறிவியல் , ஆன்டிரெட்ரோவைரல் சிகிச்சை , நீண்டது நடிப்பு அடக்குமுறை ,

Long-acting HIV-1 treatment may remove need for daily therapy

Long-acting HIV-1 treatment may remove need for daily therapy
ViiV Healthcare has received Marketing Authorisation for the first complete long-acting injectable HIV treatment in Europe.
Marketing Authorisation has been granted by the European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
The long-acting injectable regimen was preferred by the majority of clinical trial patients who tried the treatment over their previous daily oral therapy.
ViiV Healthcare, owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of the new treatment in the European Union (EU), for the treatment of HIV-1 infection in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the EU, for the treatment of HIV ....

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FDA Approves Rilpivirine, Cabotegravir as the First Long-Acting Regimen for HIV Treatment

The FDA has approved cabenuva, which consists of rilpivirine and cabotegravir, for treating HIV-1 infection in adults. This therapy is the first once-monthly, long-acting injectable to be approved for the treatment of HIV. ....

Susan Swindells , Paul Stoffels , Mathai Mammen , Department Of Internal Medicine , Janssen Research Development At Johnson , University Of Nebraska Medical Center , Viiv Healthcare , Long Acting Suppression , First Long Acting Injectable Regimen , Internal Medicine , Nebraska Medical Center , Janssen Research , மத்தாய் பாலூட்டிகள் , துறை ஆஃப் உள் மருந்து , ஜான்சன் ஆராய்ச்சி வளர்ச்சி இல் ஜான்சன் , பல்கலைக்கழகம் ஆஃப் நெப்ராஸ்கா மருத்துவ மையம் , நீண்டது நடிப்பு அடக்குமுறை , உள் மருந்து , நெப்ராஸ்கா மருத்துவ மையம் , ஜான்சன் ஆராய்ச்சி ,

GSK: ViiV Healthcare Gets FDA Approval For HIV Treatment Cabenuva

GSK: ViiV Healthcare Gets FDA Approval For HIV Treatment Cabenuva
LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) said Friday that its majority-owned specialist HIV company ViiV Healthcare has received approval from the US Food and Drug Administration for Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.
Cabenuva is provided as a co-pack with two injectable medicines - ViiV Healthcare s cabotegravir and Janssen s rilpivirine - dosed once monthly, as an option to replace the current antiretroviral or ARV regimen.
The treatment is taken in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. ....

United States , City Of , United Kingdom , Lynn Baxter , Drug Administration For Cabenuva , Viiv Healthcare , Drug Administration , North America , Antiretroviral Therapy , Long Acting Suppression , First Long Acting Injectable Regimen , New Drug Application , Health Care , ஒன்றுபட்டது மாநிலங்களில் , நகரம் ஆஃப் , ஒன்றுபட்டது கிஂக்டம் , லின் பாக்ஸ்டர் , வடக்கு அமெரிக்கா , ஆன்டிரெட்ரோவைரல் சிகிச்சை , நீண்டது நடிப்பு அடக்குமுறை , புதியது மருந்து விண்ணப்பம் , ஆரோக்கியம் பராமரிப்பு ,

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

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TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen s rilpivirine and ViiV Healthcare s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or susp ....

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